多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.446754167809670156735667476674390.43
210.536786967304675860.60
单位质量响应值RSD%判断
6459.676418.420.46数据可信
供试品溶液-J049F批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19582-958213.35213.562.8613.3513.562.86
29957-995713.87413.87
39711-971113.53113.53
49594-959413.36813.37
510162-1016214.16014.16
69404-940413.10413.10
10min118651-1865125.98826.161.3226.0126.181.31
219141-1914126.67126.69
318475-1847525.74325.77
418858-1885826.27726.30
518588-1858825.90125.92
618930-1893026.37726.40
15min125238-2523835.16735.481.0835.2335.551.08
225537-2553735.58335.65
325377-2537735.36035.43
425787-2578735.93236.00
525105-2510534.98135.05
625743-2574335.87035.94
20min130409-3040942.37242.422.2642.5042.552.25
230337-3033742.27242.40
330029-3002941.84341.97
430359-3035942.30242.43
529777-2977741.49141.62
631752-3175244.24344.37
30min136508-3650850.87050.891.1751.0751.091.16
236678-3667851.10751.30
336145-3614550.36550.56
436887-3688751.39851.59
535921-3592150.05250.25
637013-3701351.57451.77
45min142664-4266459.44859.891.3459.7360.161.34
243169-4316960.15260.43
342357-4235759.02059.30
443449-4344960.54260.82
542455-4245559.15759.43
643772-4377260.99261.28
60min147549-4754966.25566.111.1166.6366.491.11
247566-4756666.27966.66
346710-4671065.08665.46
448014-4801466.90367.29
546925-4692565.38565.76
647914-4791466.76467.15
90min152635-5263573.34273.531.3373.8374.021.33
252892-5289273.70074.19
352248-5224872.80373.29
453215-5321574.15074.64
551839-5183972.23372.72
653809-5380974.97875.48
120min156477-5647778.69578.440.9079.3179.050.90
256359-5635978.53179.15
355694-5569477.60478.21
456636-5663678.91779.53
555681-5568177.58678.19
656918-5691879.31079.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157652-5765280.33280.300.7181.0781.040.71
257809-5780980.55181.30
357127-5712779.60180.34
458032-5803280.86281.61
557137-5713779.61580.35
658001-5800180.81981.57
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.446841968719686906864068913686760.26
210.536880169022689120.23
单位质量响应值RSD%判断
6578.166544.350.37数据可信
供试品溶液-J049F批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18548-854811.68913.447.2811.6913.447.28
29612-961213.14413.14
39788-978813.38513.38
410546-1054614.42114.42
510352-1035214.15614.16
610109-1010913.82413.82
10min117942-1794224.53526.243.7224.5526.263.73
219022-1902226.01226.03
319055-1905526.05726.08
420015-2001527.36927.39
519538-1953826.71726.74
619559-1955926.74626.77
15min124938-2493834.10135.772.4534.1635.842.45
226155-2615535.76635.83
326194-2619435.81935.88
426450-2645036.16936.24
526460-2646036.18336.25
626767-2676736.60236.67
20min129913-2991340.90442.151.7441.0242.271.75
230704-3070441.98642.11
330817-3081742.14142.27
431177-3117742.63342.76
530811-3081142.13242.26
631502-3150243.07743.21
30min136865-3686550.41151.421.4650.6051.611.46
237019-3701950.62150.82
337813-3781351.70751.90
438132-3813252.14352.34
537642-3764251.47351.67
638138-3813852.15252.35
45min143273-4327359.17360.301.4959.4460.591.50
243371-4337159.30759.59
344347-4434760.64260.92
444468-4446860.80861.10
544186-4418660.42260.71
644958-4495861.47861.76
60min148026-4802665.67366.440.9766.0466.820.98
248032-4803265.68166.06
348529-4852966.36166.74
448895-4889566.86167.25
548939-4893966.92167.31
649102-4910267.14467.53
90min153454-5345473.09574.051.0273.5774.541.02
253514-5351473.17773.67
354515-5451574.54675.04
454160-5416074.06174.56
554764-5476474.88775.38
654493-5449374.51675.02
120min156703-5670377.53878.720.9078.1479.330.90
257315-5731578.37578.98
358117-5811779.47280.09
457474-5747478.59379.22
557849-5784979.10579.73
657932-5793279.21979.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限158369-5836979.81679.960.4680.5480.700.45
258417-5841779.88280.62
358329-5832979.76280.51
458175-5817579.55180.31
558921-5892180.57181.32
658625-5862580.16680.92
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.446775467523671746783367738676040.40
210.536938369339693610.05
单位质量响应值RSD%判断
6475.486586.991.21数据可信
供试品溶液-J050F批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19486-948613.03214.117.8813.0314.117.87
29199-919912.63812.64
310531-1053114.46814.47
411423-1142315.69315.69
510416-1041614.31014.31
610564-1056414.51314.51
10min117593-1759324.17026.166.6724.1926.186.67
217294-1729423.75923.78
319678-1967827.03427.06
420320-2032027.91627.94
519826-1982627.23727.26
619538-1953826.84226.87
15min123224-2322431.90634.746.9631.9734.806.96
222844-2284431.38431.44
326377-2637736.23736.31
426757-2675736.75936.83
526240-2624036.04936.12
626271-2627136.09236.16
20min127356-2735637.58241.317.0337.7041.447.03
227396-2739637.63737.75
331061-3106142.67242.80
431710-3171043.56443.70
531071-3107142.68642.82
631831-3183143.73043.86
30min133238-3323845.66350.037.0245.8450.227.02
233032-3303245.38045.56
337639-3763951.70951.91
438134-3813452.38952.60
537966-3796652.15952.36
638477-3847752.86153.06
45min139286-3928653.97258.936.8854.2359.216.88
238947-3894753.50653.76
344205-4420560.73061.02
444969-4496961.77962.07
544750-4475061.47961.77
645233-4523362.14262.43
60min143774-4377460.13865.056.2460.4865.436.24
243365-4336559.57659.92
348920-4892067.20767.60
448988-4898867.30167.70
549207-4920767.60267.99
649850-4985068.48568.88
90min148918-4891867.20572.785.7667.6573.265.76
249312-4931267.74668.19
353841-5384173.96874.47
455192-5519275.82476.33
554990-5499075.54676.05
655599-5559976.38376.89
120min152286-5228671.83277.865.8672.3978.475.86
252684-5268472.37872.93
357767-5776779.36279.98
458990-5899081.04281.68
558537-5853780.41981.05
659802-5980282.15782.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限153974-5397474.15179.465.2774.8380.205.28
253965-5396574.13874.81
358910-5891080.93281.69
459682-5968281.99282.76
560006-6000682.43883.20
660514-6051483.13583.91
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.446743567596676186757667283675020.21
210.536909069289691900.21
单位质量响应值RSD%判断
6465.716570.751.14数据可信
供试品溶液-J050F批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17963-796310.96113.6414.7010.9613.6414.71
28196-819611.28211.28
310672-1067214.69114.69
410642-1064214.64914.65
510511-1051114.46914.47
611454-1145415.76715.77
10min116001-1600122.02625.4310.5022.0425.4510.52
216065-1606522.11422.13
320346-2034628.00728.03
419385-1938526.68426.71
519087-1908726.27426.30
619948-1994827.45927.49
15min121855-2185530.08534.248.9730.1434.308.97
222420-2242030.86230.92
327283-2728337.55637.63
426055-2605535.86635.93
525180-2518034.66234.73
626432-2643236.38536.46
20min126295-2629536.19640.568.4936.3040.688.50
226295-2629536.19636.30
331664-3166443.58743.72
430777-3077742.36642.49
530365-3036541.79941.92
631416-3141643.24643.38
30min131933-3193343.95749.458.1444.1249.648.14
232699-3269945.01245.18
338992-3899253.67553.88
437503-3750351.62551.82
536472-3647250.20650.40
637955-3795552.24752.45
45min138503-3850353.00158.297.0653.2458.567.07
239020-3902053.71353.96
346198-4619863.59463.89
443801-4380160.29460.58
542971-4297159.15259.43
643567-4356759.97260.26
60min142616-4261658.66364.496.8958.9964.866.90
243152-4315259.40159.73
350447-5044769.44369.84
449014-4901467.47067.86
547450-4745065.31765.70
648396-4839666.62067.01
90min148079-4807966.18372.256.4766.6172.736.48
248608-4860866.91167.34
356479-5647977.74678.26
454453-5445374.95775.46
553093-5309373.08573.57
654220-5422074.63775.14
120min152001-5200171.58277.235.4972.1277.825.50
252643-5264372.46673.01
359573-5957382.00582.65
458002-5800279.84380.47
556716-5671678.07378.68
657668-5766879.38380.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限152726-5272672.58078.345.5073.2379.075.52
253628-5362873.82274.48
360886-6088683.81384.60
458660-5866080.74981.50
557431-5743179.05779.80
658149-5814980.04580.80
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